Diagnostic Tool and Method of Use

ABSTRACT

A diagnostic tool and methods of using the tool are provided to quantify an amount of nasal collapse in a patient. The diagnostic tool includes a mask with an endoscope port and an opening to allow air flow, an endoscope with a camera adapted to take an image of the nasal valve, and an air flow sensor adapted to measure an inhalation rate of the patient. The diagnostic tool can quantify a size difference between the nasal valve during inhalation and zero flow by calculating a percentage difference in an area or one or more dimensions of the nasal valve during inhalation and zero flow.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/331,946, filed Mar. 7, 2019, which is a U.S. National Stage filingunder 35 U.S.C. § 371 of International Application No.PCT/US2017/051827, filed Sep. 15, 2017, which claims priority to U.S.Patent Application No. 62/395,936 filed Sep. 16, 2016 titled “DiagnosticTool and Methods of Use”, the contents of which are incorporated hereinby reference in their entirety.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference in their entirety to the sameextent as if each individual publication or patent application wasspecifically and individually indicated to be incorporated by reference.

FIELD

The present disclosure relates generally to observing and treating nasalobstruction, such as nasal valve collapse.

BACKGROUND

Nasal obstruction is typically assessed via a qualitative quality oflife questionnaire called the NOSE questionnaire (Nasal ObstructionSymptom Evaluation). Nasal obstruction has three primary contributors:septal deviation, turbinate hypertrophy, and constriction of the nasalvalve. Nasal valve collapse is a dynamic constriction of the nasal valvedue to the negative pressure generated during inspiration. Septaldeviation and turbinate hypertrophy can be diagnosed endoscopically andare frequently treated surgically by ENT physicians.

Nasal valve collapse is more difficult to diagnose and severe cases aretypically treated by facial plastic surgeons in substantially invasivesurgical procedures relying on cartilage grafting such as Batten grafts,spreader grafts, butterfly grafts, alar strut grafts, etc. Spirox'sLatera® Absorbable Nasal Implant is a polymer graft which enablestreatment of nasal valve collapse in a minimally invasive manner.Examples of nasal implants are disclosed in US 2016/0058556. The nasalvalve collapse treatments identified above typically function by addingstiffness to the nasal lateral wall to reduce collapse duringinspiration.

It would be highly desirable to quantify the degree of nasal valvecollapse before and after any surgical treatment to enable an objectiveassessment of the particular treatment's effectiveness in reducingcollapse. There are currently no broadly accepted methods for performingthis quantification of degree of valve collapse.

Several methods have been developed to quantify nasal obstruction, butthese methods do not capture and sometimes mask the dynamic effects ofnasal valve collapse. These methods include: acoustic rhinometry,rhinomanometry, and rhinoresistometry. These methods have been reportedto have limited relevance due to their lack of correlation to patientreported subjective nasal obstruction via the NOSE score. Regardless,these methods are not designed to quantify nasal valve collapse forvarious reasons.

Acoustic rhinometry is a static (e.g. non-breathing) quantification ofthe cross sectional area of the nasal airway. As a static measurement itis inherently unable to capture the constricting effects of dynamicvalve collapse. FIG. 1 illustrates an example of acoustic rhinometryincluding the acoustic rhinometer 10 and an example of an output 20.

Rhinomanometry relies on blocking one nostril and measuring the pressurein that closed nostril at the same time as the flow rate through theopposing nostril. This method employs a mask as well as an adhesive sealon one nostril. The result is that the mask and the tape affect thenasal lateral wall at the location of the nasal valve and significantlyalter the amount of dynamic collapse confounding the measurements. Inaddition, data collected is often processed with the assumption of alinear relationship between pressure and flow which is not accurate ifnasal valve collapse causes an anatomical self-limiting of flow at highinspiratory pressures. FIGS. 2A-2D illustrate examples of rhinomanometrydevices 30, 35, 40, and 45.

Rhinoresistometry involves additional data analysis on the same pressureand flow measurements of rhinomanometry and suffers the same drawbacksrelated to dynamic nasal valve collapse.

One known method for quantification of nasal valve collapse (or lateralnasal wall insufficiency) is a grading system described by Tsao,Fijalkowski, and Most which utilizes direct endoscopic visualization ofnasal lateral wall movement and classifies the degree of collapse asgrade 0, 1, 2, or 3 based on the evaluators visual assessment of thepercentage of reduction in distance between the lateral wall and thenasal septum at the location of the internal valve. FIG. 3C illustratesthe Most grading scale for nasal valve collapse along with images (FIG.3A and FIG. 3B) of the nasal valve while inhaling 55 and exhaling 50.The distance between the lateral wall and the nasal septum is shown withlines 52, 57. The length of the lines 52, 57 can be compared andclassified based on the Most grading scale (FIG. 3C). There are numerousvariables which limit the resolution of the Most grading system to 1-3.The most significant of these variables is the magnitude of inspiratoryflow which the patient generates as the evaluation takes place. Higherinspiratory effort results in a greater negative pressure in the lungsand a higher air velocity through the constricted nasal valve whichfurther reduces the pressure in the valve and increases collapse. Thusthe degree of inspiratory effort significantly affects the magnitude ofnasal valve collapse and this variable is uncontrolled.

There is currently no method for higher resolution quantification of themagnitude of nasal valve collapse. A need exists for improved systemsand methods for quantifying nasal valve collapse.

SUMMARY OF THE DISCLOSURE

The present invention relates to diagnostic tools and methods of usingthe diagnostic tools to quantify the nasal collapse of a nasal valve ofa patient.

In general, in one embodiment, methods for determining a nasal valvecollapse of a patient are provided. The methods include receiving one ormore images of a nasal valve of a patient taken while the patientinhales and between exhalation and inhalation, the images taken with anendoscope having a camera that passes through a port in a mask forming aseal with a facial structure of the patient; measuring an air flow rateof the patient across an opening of the mask while the patient inhalesand between exhalation and inhalation; and comparing the one or moreimages of the nasal valve while the patient inhales and betweenexhalation and inhalation thereby quantifying a size difference betweenthe nasal valve during inhalation and during a period between exhalationand inhalation.

This and other embodiments can include one or more of the followingfeatures. Quantifying the size difference between the nasal valve duringinhalation and during a period between exhalation and inhalation canfurther include determining a first relative distance between a septumand a lateral wall of the nasal valve during inhalation; determining asecond relative distance between the septum and the lateral wall of thenasal valve during the period between exhalation and inhalation; andcalculating the first relative distance divided by the second relativedistance to quantify the nasal valve collapse.

The methods can further include receiving one or more images of thenasal valve of the patient taken at a plurality of inhalation rates. Themethods can further include determining a plurality of relativedistances between the septum and the lateral wall of the nasal valve forthe plurality of inhalation rates.

The methods can further include receiving an annotation of the image ofthe nasal valve when the patient inhales, the annotation done by aphysician to indicate a distance between the septum and the lateral wallin the image of the nasal valve. The methods can further includedetermining a relative distance between the septum and the lateral wallbased on the annotation of the image of the nasal valve when the patientinhales.

The methods can further include receiving an annotation of the image ofthe nasal valve during the period between exhalation and inhalation, theannotation done by a physician to indicate a distance between the septumand the lateral wall in the image of the nasal valve. The methods canfurther include determining a relative distance between the septum andthe lateral wall based on the annotation of the image of the nasal valveduring the period between exhalation and inhalation.

The methods can further include receiving a time stamp of the pluralityof images of the nasal valve and the measured air flow rates. Themethods can further include displaying an air flow rate at a first timeand a corresponding image of the nasal valve at the first time.

The methods can further include displaying an air flow rate graphshowing the air flow rate versus time. The methods can further includedisplaying an image of the nasal valve. The methods can further includereceiving an input from a user indicating a time of interest on the airflow rate graph; and displaying a corresponding image of the nasal valveat the time of interest.

In some embodiments quantifying the size difference between the nasalvalve during inhalation and the period between exhalation and inhalationcan include calculating a percentage difference in an area or one ormore dimensions of the nasal valve during inhalation and the periodbetween exhalation and inhalation.

The methods can further include displaying a graph of a quantificationof the nasal valve collapse at a plurality of inhalation rates versusair flow rate.

The methods can further include engaging the mask with the facial areaof the patient to form a seal around the nose and the mouth of thepatient to substantially seal the nose and mouth from an exterior of themask. The methods can further include guiding the patient to apre-determined inhalation rate. In some embodiments the one or moreimages include a video of the nasal valve. In some embodiments the maskdoes not alter a physical structure or physical properties of a nasaltissue of the patient. The methods can further include positioning theendoscope with the camera adjacent to a nasal valve of the patient.

In general, in one embodiment, methods for determining nasal valvecollapse are provided. The methods can include receiving a first imageof a nasal valve of a patient taken at a first time; receiving a firstmeasurement of an airflow passing through the nasal valve of the patientat substantially the first time; determining a first relative distancebetween a septum and a lateral wall of the nasal valve of the patientbased on the first image of the nasal valve at the first time; receivinga second image of the nasal valve of a patient at a second timedifferent from the first time; receiving a second measurement of anairflow passing through the nasal valve of the patient at substantiallythe second time; determining a second relative distance between theseptum and the lateral wall of the nasal valve of the patient based onthe second image of the nasal valve at the second time; and comparingthe first relative distance and second relative distance to provide aquantitative indication of the nasal valve collapse. In some embodimentsthe first time corresponds to when the patient is inhaling and thesecond time corresponds to a period between exhalation and inhalation.In some embodiments the first time and the second time are on a firstday, wherein the first day is prior to providing a treatment to thepatient.

The methods can further include receiving a first image of a nasal valveof a patient taken at a first time on a second day, wherein the secondday is after the first day and a treatment provided to the patient;receiving a first measurement of an airflow passing through the nasalvalve of the patient at substantially the first time on the second day;determining a first relative distance between a septum and a lateralwall of the nasal valve of the patient based on the first image of thenasal valve at the first time on the second day; receiving a secondimage of the nasal valve of a patient at a second time different fromthe first time on the second day; receiving a second measurement of anairflow passing through the nasal valve of the patient at substantiallythe second time on the second day; determining a second relativedistance between the septum and the lateral wall of the nasal valve ofthe patient based on the second image of the nasal valve at the secondtime on the second day; and comparing the first relative distance andsecond relative distance to provide a quantitative indication of thenasal valve collapse on the second day. The methods can further includecomparing the quantitative indication of the nasal valve collapse on thefirst day to the quantitative indication of the nasal valve collapse onthe second day.

In some embodiments the quantitative indication of the nasal valvecollapse correlates to the first relative distance divided by the secondrelative distance. The methods can further include displaying thequantitative indication of the nasal valve collapse and the secondmeasurement of the air flow.

In some embodiments determining the first relative distance between theseptum and the lateral wall of the nasal valve of the patient includesdetermining a number of pixels in an annotation provided by a physiciandrawing a line between the septum and the lateral wall in the firstimage.

In some embodiments determining the second relative distance between theseptum and the lateral wall of the nasal valve of the patient includesdetermining a number of pixels in an annotation provided by a physiciandrawing a line between the septum and the lateral wall in the secondimage.

The methods can further include displaying an air flow rate graphshowing the air flow rate versus time. The methods can further includedisplaying an image of the nasal valve. The methods can further includereceiving an input from a user indicating a time of interest on the airflow rate graph; and displaying a corresponding image of the nasal valveat the time of interest.

The methods can further include displaying a graph of a quantitativeindication of the nasal valve collapse versus air flow rate.

In general, in one embodiment systems for measuring a nasal valvecollapse of a patient are provided. The systems can include a facialmask adapted to form a seal with a facial structure of the patient, thefacial mask including an endoscope port and an opening to allow airflow; an air flow sensor in fluid communication with the opening of thefacial mask configured to measure an air flow across the opening whenthe patient inhales; an endoscope with a camera adapted to pass throughthe endoscope port in the facial mask; and a data acquisition moduleadapted to receive a plurality of images from the camera and a pluralityof air flow measurements from the air flow sensor. In one aspect thedata acquisition module is configured to synchronize the plurality ofimages from the camera and the plurality of air flow measurements fromthe air flow sensor using a plurality of time stamps associated with theplurality of images and the plurality of air flow measurements. In someembodiments the facial mask is adapted to engage with the facialstructure of the patient without changing a nasal anatomy of thepatient. In some embodiments the data acquisition module is furtheradapted to analyze the air flow measurement, the picture of the nasalvalve taken during inhalation, and the picture of the nasal valve duringzero flow thereby quantifying a nasal collapse of the patient. In someembodiments quantifying the nasal collapse of the patient includescomparing the picture of the nasal valve taken during inhalation and thepicture of the nasal valve during zero flow to calculate a percentagedifference in an area or one or more dimensions of the nasal valvebetween the picture of the nasal valve taken during inhalation and thepicture of the nasal valve during zero flow. In some embodiments thesystem is configured to perform any of the steps described herein.

In general, in one embodiment, devices for measuring a force areprovided. The devices can include a plunger at a distal end of a shaft,the plunger coupled to a force gauge adapted to measure a force on theplunger, the plunger adapted to engage with an exterior surface of alateral wall of a nose of a patient; and a displacement guide adapted toprovide a visual indication of a length of a displacement of theplunger, the displacement guide including a predetermined distance. Insome embodiments the displacement guide includes a ruler. In someembodiments the predetermined distance is about 5 mm or less.

In general, in one embodiment, methods are provided for measuring aproperty of a lateral wall of a nose of a patient. The methods caninclude engaging a plunger coupled to a force gauge with an exteriorportion of the lateral wall of the nose; applying a force on the plungerto deflect the plunger to a predetermined distance; and recording areading of the force gauge when the plunger is deflected to thepredetermined distance. The methods can further include measuring thedeflection of the plunger using a ruler on or adjacent to a portion ofthe plunger. In some embodiments the predetermined distance is about 5mm or less.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe claims that follow. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIG. 1 is a picture of a prior art method of observing nasalobstruction.

FIGS. 2A-2D illustrate another prior art technique for observing nasalobstruction.

FIGS. 3A-3B illustrate images of the nasal valve during exhalation andinspiration, respectively. FIG. 3C shows the Most grading scale forendoscopic evaluation of nasal valve collapse.

FIGS. 4A-4D illustrate a diagnostic tool for quantifying nasal valvecollapse in accordance with some embodiments.

FIGS. 5A-5B illustrate an example of a graphical user interface (GUI)that can be used with methods for quantifying the nasal valve collapsein accordance with some embodiments.

FIGS. 6A-6B illustrate an example of a graphical user interface (GUI)that can be used with methods for quantifying the nasal valve collapsein accordance with some embodiments.

FIGS. 7A-7B illustrate exemplary graphs showing nasal valve collapseversus airflow for a patient's left nostril and right nostril,respectively, in accordance with some embodiments.

FIGS. 8A-8B illustrate additional examples of a graphical user interface(GUI) that can be used with methods for quantifying the nasal valvecollapse in accordance with some embodiments.

FIG. 9 illustrates a device for measuring the force for deflecting aportion of the nasal lateral wall in accordance with some embodiments.

DETAILED DESCRIPTION

To improve resolution of the Most grading scale for nasal valvecollapse, a method has been developed for capturing endoscopicvisualization of lateral wall movement while simultaneously capturingnasal air flow rate without physically impeding the lateral wallmovement.

The method includes the use of an airflow sensor connected to a fullface mask to capture inspiratory air flow rate. The mask is designed toinclude a port below the nose which enables the introduction of anendoscope through a seal. Thus both airflow measurements and endoscopicvideo can be collected simultaneously. The method further includessoftware to synchronously capture both endoscopic video of lateral wallmovement and air flow rate data.

Methods for determining a nasal valve collapse of a patient areprovided. The methods can include: receiving one or more images of anasal valve of a patient taken while the patient inhales and betweenexhalation and inhalation, the images taken with an endoscope having acamera that passes through a port in a mask forming a seal with a facialstructure of the patient; measuring an air flow rate of the patientacross an opening of the mask while the patient inhales and betweenexhalation and inhalation; and comparing the one or more images of thenasal valve while the patient inhales and between exhalation andinhalation thereby quantifying a size difference between the nasal valveduring inhalation and during a period between exhalation and inhalation.

Quantifying the size difference between the nasal valve duringinhalation and during a period between exhalation and inhalation caninclude determining a first relative distance between a septum and alateral wall of the nasal valve during inhalation, determining a secondrelative distance between the septum and the lateral wall of the nasalvalve during the period between exhalation and inhalation, andcalculating the first relative distance divided by the second relativedistance to quantify the nasal valve collapse.

In some embodiments the methods can further include receiving one ormore images of the nasal valve of the patient taken at a plurality ofinhalation rates. The methods can also include determining a pluralityof relative distances between the septum and the lateral wall of thenasal valve for the plurality of inhalation rates.

In some embodiments the methods include receiving an annotation of theimage of the nasal valve when the patient inhales, the annotation doneby a physician to indicate a distance between the septum and the lateralwall in the image of the nasal valve. The methods can includedetermining a relative distance between the septum and the lateral wallbased on the annotation of the image of the nasal valve when the patientinhales.

In some embodiments the methods include receiving an annotation of theimage of the nasal valve during the period between exhalation andinhalation, the annotation done by a physician to indicate a distancebetween the septum and the lateral wall in the image of the nasal valve.The methods can include determining a relative distance between theseptum and the lateral wall based on the annotation of the image of thenasal valve during the period between exhalation and inhalation.

In some embodiments the methods include receiving a time stamp of theplurality of images of the nasal valve and the measured air flow rates.The methods can further include displaying an air flow rate at a firsttime and a corresponding image of the nasal valve at the first time.

In some embodiments the methods include displaying an air flow rategraph showing the air flow rate versus time. The methods can furtherinclude displaying an image of the nasal valve. The methods can alsoinclude receiving an input from a user indicating a time of interest onthe air flow rate graph and displaying a corresponding image of thenasal valve at the time of interest.

In some embodiments the methods include quantifying the size differencebetween the nasal valve during inhalation and the period betweenexhalation and inhalation includes calculating a percentage differencein an area or one or more dimensions of the nasal valve duringinhalation and the period between exhalation and inhalation.

In some embodiments the methods include displaying a graph of aquantification of the nasal valve collapse at a plurality of inhalationrates versus air flow rate.

In some embodiments the methods include engaging the mask with thefacial area of the patient to form a seal around the nose and the mouthof the patient to substantially seal the nose and mouth from an exteriorof the mask. In some embodiments the methods include guiding the patientto a pre-determined inhalation rate. In some embodiments the methodsinclude the one or more images include a video of the nasal valve. Insome embodiments the methods include the mask does not alter a physicalstructure or physical properties of a nasal tissue of the patient. Insome embodiments the methods include positioning the endoscope with thecamera adjacent to a nasal valve of the patient.

Methods for determining nasal valve collapse are provided. In someembodiments the methods include, receiving a first image of a nasalvalve of a patient taken at a first time, receiving a first measurementof an airflow passing through the nasal valve of the patient atsubstantially the first time, determining a first relative distancebetween a septum and a lateral wall of the nasal valve of the patientbased on the first image of the nasal valve at the first time, receivinga second image of the nasal valve of a patient at a second timedifferent from the first time, receiving a second measurement of anairflow passing through the nasal valve of the patient at substantiallythe second time, determining a second relative distance between theseptum and the lateral wall of the nasal valve of the patient based onthe second image of the nasal valve at the second time and comparing thefirst relative distance and second relative distance to provide aquantitative indication of the nasal valve collapse. In some embodimentsthe first time corresponds to when the patient is inhaling and thesecond time corresponds to a period between exhalation and inhalation.

In some embodiments the first time and the second time are on a firstday, wherein the first day is prior to providing a treatment to thepatient. In some embodiments the methods include receiving a first imageof a nasal valve of a patient taken at a first time on a second day,wherein the second day is after the first day and a treatment providedto the patient; receiving a first measurement of an airflow passingthrough the nasal valve of the patient at substantially the first timeon the second day; determining a first relative distance between aseptum and a lateral wall of the nasal valve of the patient based on thefirst image of the nasal valve at the first time on the second day;receiving a second image of the nasal valve of a patient at a secondtime different from the first time on the second day; receiving a secondmeasurement of an airflow passing through the nasal valve of the patientat substantially the second time on the second day; determining a secondrelative distance between the septum and the lateral wall of the nasalvalve of the patient based on the second image of the nasal valve at thesecond time on the second day; and comparing the first relative distanceand second relative distance to provide a quantitative indication of thenasal valve collapse on the second day. The methods can also includecomparing the quantitative indication of the nasal valve collapse on thefirst day to the quantitative indication of the nasal valve collapse onthe second day.

In some embodiments the quantitative indication of the nasal valvecollapse correlates to the first relative distance divided by the secondrelative distance. The methods can further include displaying thequantitative indication of the nasal valve collapse and the secondmeasurement of the air flow.

In some embodiments the methods include determining the first relativedistance between the septum and the lateral wall of the nasal valve ofthe patient includes determining a number of pixels in an annotationprovided by a physician drawing a line between the septum and thelateral wall in the first image.

In some embodiments the methods include determining the second relativedistance between the septum and the lateral wall of the nasal valve ofthe patient includes determining a number of pixels in an annotationprovided by a physician drawing a line between the septum and thelateral wall in the second image.

In some embodiments the methods include displaying an air flow rategraph showing the air flow rate versus time. The methods can alsoinclude displaying an image of the nasal valve. The methods can alsoinclude receiving an input from a user indicating a time of interest onthe air flow rate graph and displaying a corresponding image of thenasal valve at the time of interest.

In some embodiments the methods include displaying a graph of aquantitative indication of the nasal valve collapse versus air flowrate.

Systems for measuring nasal valve collapse are also provided herein. Insome embodiments the systems include: a facial mask adapted to form aseal with a facial structure of the patient, the facial mask includingan endoscope port and an opening to allow air flow; an air flow sensorin fluid communication with the opening of the facial mask configured tomeasure an air flow across the opening when the patient inhales; anendoscope with a camera adapted to pass through the endoscope port inthe facial mask; and a data acquisition module adapted to receive aplurality of images from the camera and a plurality of air flowmeasurements from the air flow sensor. The data acquisition module canbe configured to synchronize the plurality of images from the camera andthe plurality of air flow measurements from the air flow sensor using aplurality of time stamps associated with the plurality of images and theplurality of air flow measurements. The facial mask can be adapted toengage with the facial structure of the patient without changing a nasalanatomy of the patient.

In some embodiments the data acquisition module is further adapted toanalyze the air flow measurement, the picture of the nasal valve takenduring inhalation, and the picture of the nasal valve during zero flowthereby quantifying a nasal collapse of the patient. Quantifying thenasal collapse of the patient can include comparing the picture of thenasal valve taken during inhalation and the picture of the nasal valveduring zero flow to calculate a percentage difference in an area or oneor more dimensions of the nasal valve between the picture of the nasalvalve taken during inhalation and the picture of the nasal valve duringzero flow.

Devices for measuring a force are also provided. In some embodiments thedevices include a plunger at a distal end of a shaft, the plungercoupled to a force gauge adapted to measure a force on the plunger, theplunger adapted to engage with an exterior surface of a lateral wall ofa nose of a patient; and a displacement guide adapted to provide avisual indication of a length of a displacement of the plunger, thedisplacement guide including a predetermined distance. The displacementguide can includes a ruler. The predetermined distance can be about 5 mmor less.

Methods of measuring a property of a lateral wall of a nose of a patientare also provided. The methods can include engaging a plunger coupled toa force gauge with an exterior portion of the lateral wall of the nose,applying a force on the plunger to deflect the plunger to apredetermined distance, and recording a reading of the force gauge whenthe plunger is deflected to the predetermined distance. The methods canalso include measuring the deflection of the plunger using a ruler on oradjacent to a portion of the plunger. The predetermined distance can beabout 5 mm or less.

FIGS. 4A-4D illustrate a device for quantifying nasal valve collapse inaccordance with some embodiments. FIG. 4A shows the full face mask 100with an exhale valve 104 and a port for receiving an endoscope 102. Theexhale valve can be engaged with a tube 106 such that the exhale valveis in fluid communication with the flow sensor 108 (FIG. 4B). The port104 for receiving the endoscope can form a seal with the endoscope tominimize air flow across the seal when the endoscope passes through theport. FIG. 4B also shows a portion of the system including the tube 106,a flow sensor 108, power source 110, and a data acquisition module 112.FIG. 4C illustrates a view of the endoscope 120 passing through the port102 on the mask 100. FIG. 4D illustrates the mask 100 and endoscope 120.The endoscope 120 includes optics for obtaining an image of the anatomyalong with an endoscopic camera for recording the image of the anatomyand transmitting the image to the data acquisition module 112. The dataacquisition module 112 can receive the air flow data from the flowsensor 108 along with any images or video captured by the camera on theendoscope. Data from the endoscope can be provided to the dataacquisition module 112 through a cable 114, such as a USB cable. In somecases the data transmission can be done wirelessly.

The data acquisition module 112 can time sync the endoscopic images withthe flow meter data from the flow sensor 108. For example, the dataacquisition module 112 can assign time stamps to the air flow data andthe image frames from the endoscopic camera and synchronize the air flowdata and the image frames. The flow sensor 108 can sample the air flowat a higher frequency than the frequency of the images of the taken bythe endoscopic camera. For example the air flow data can be measuredwith a frequency in the neighborhood of KHZ, e.g. on the order of athousand times a second. In contrast, the endoscopic camera typicallycaptures images on the order of 30-60 frames per second. The dataacquisition module 112 can synchronize the time stamps for the imagesand the air flow data and provide the synchronized images and air flowdata to the user, such as the doctor examining and/or treating thepatient.

The data acquisition module 112 can include a processor to analyze thereceived data as described herein. The data acquisition module 112 cancommunicate with an external computing device, such as a hand heldcomputer, where the images and data can be displayed in real time ormanipulated by the user after the data is collected. A companionapplication, such as a tablet or smartphone application, can be providedwith the device to facilitate the collection and analysis of the patientdata. An example of a graphical user interface (GUI) is shown in FIGS.5A-6B that can be used with the external computing device or thecompanion application.

The air flow sensor 108 can measure air flow rates that are typicallygenerated by a human. For example, in some embodiments the air flowsensor is capable of measuring air flow rates of about 0 liters perminute up to about 100 liters per minute.

The device enables the physician to advise the patient to breathe with atarget amount of inspiratory flow for consistent measurements. Thephysician can provide instructions to the user to modify the inspiratoryor inhalation flow rate to meet a desired or pre-determined level.Typically, the physician can instruct the patient to breathe at severaldifferent levels, for example, the patient can be instructed to breathein with a low breath, medium breath, and high breath. Measuring thenasal valve collapse at several different air flow rates allows thephysician to quantify and observe the nasal valve collapse at differentair flow rates. The different measurements also allow for a plot of thecollapse versus air flow rate to be determined as described in detailbelow. Typically, the correlation of the collapse versus air flow ratecorresponds to a substantially linear relationship. The slope of theplot corresponds to the spring constant for the patient anatomy.

The system also allows the physician to observe the amount of nasalvalve collapse simultaneously with measuring the air flow passingthrough the nasal valve. Observing the nasal valve and the movement ofthe lateral wall during breathing also allows the physician to getadditional information about the patient anatomy to improve diagnosis ofthe issues that the patient may be experiencing. There are severaldifferent causes of nasal obstruction. Thus if the physician observesthe nasal valve during inspiration and the lateral wall does notsignificantly collapse then the physician can learn that the patient isless likely to benefit from a nasal implant like the Latera® implant andcan further explore additional causes of nasal obstruction. Thephysician can also observe the size of the nasal valve of the patient,such as whether the patient has a wide open nasal valve, or a staticallynarrow nasal valve. The physician can also directly observe theflexibility of the lateral wall. Thus, if the patient has a flexiblelateral wall and a large nasal valve then nasal valve collapse is lesslikely to be a problem. In contrast, if the patient has a flexiblelateral wall and a narrow nasal valve then nasal valve collapse is morelikely to be a problem that can impact breathing.

In some cases the physician can tell from the plot of air flow rateversus time whether the patient is experiencing substantial nasal valvecollapse. For example, if the plot of the air flow rate duringinhalation initially goes up and then sharply decreases to a lowerplateau then it is likely that the nasal valve collapsed with theinitial inhalation to restrict the air flow rate to the lower plateauvalue.

FIG. 5A-5B illustrates an example of a method for quantifying the nasalvalve collapse in accordance with some embodiments. The graphical userinterface (GUI) 200 illustrated in FIGS. 5A-5B can be displayed on acomputer screen, tablet computer, smart phone, or other computer devicewith a display. FIG. 5A illustrates a GUI 200 with an image 202 of thelateral wall and nasal valve captured by the camera on the endoscopealong with air flow measurements 204 of the inhalation rate of the usercaptured by the air flow sensors of the diagnostic tool. The air flowrates are shown in standard liters per minute (SLM) versus time. FIG. 5Bshows a similar GUI 200 as FIG. 5A but the image of the nasal valve 202shows the nasal lateral wall collapsed during inhalation.

Still frames from a video captured by the endoscopic camera can beselected based on the corresponding flow rates for both thenon-inspiring baseline image, and the image at the desired inspiratoryflow rate.

The software, on the device or operated by a remote computer, thenenables a linear measurement to be obtained for both baseline andinspiratory images and these measurements are then used to calculate apercentage reduction in distance between septum and lateral wall due tonasal valve collapse.

The device and methods output a high resolution measurement of lateralwall collapse at a specific air flow rate. In contrast to some prior arttechniques the output is a quantitative measurement of the nasal valvecollapse. The use of the full face mask can prevent modifying theproperties of the nasal lateral wall to further improve the usefulnessof the diagnostic tool and associated methods. The present disclosureallows for a significant improvement in diagnostics of degree of nasalvalve collapse and objective measurement of the changes in the abilityof the lateral wall to resist collapse after surgical correction thusenabling comparison of the various surgical correction methods.

FIGS. 6A-6B illustrate how the physician or other user of theapplication can review and annotate the collected data with the GUI 200.The GUI 200 allows the physician or other user to pick a point on thetimeline showing the air flow measurements and the corresponding image202 of the septum and lateral wall is displayed. The user can draw aline 210 a, 210 b to indicate the distance between the lateral wall andthe septum. The line 210 a shows the distance between the lateral walland the septum with the GUI 200 showing the air flow in SLPM as zero(e.g. zero flow). The line 210 b shows the distance between the lateralwall and the septum with the GUI 200 showing the air flow of 34.08 SLPM.The extent of the collapse can be determined by dividing the length ofline 210 b/210 a. In some cases the length of the lines 210 a/210 b thatare drawn can be determined by counting the pixels in the line.

In some embodiments the user could trace the perimeter of the nasalvalve (e.g. septum and lateral wall) and the program can calculate therelative area contained in the nasal valve. In some cases the methodscan include applying image analysis techniques to measure the area ofthe space between the septum and lateral wall to automatically determinethe area or length between the septum and lateral wall at zero flow andat another flow rate followed by calculating the percentage differencebetween the two measurements.

The physician or user can select the specific time and corresponding airflow and images of nasal anatomy to observe using the GUI 200. In somecases the physician uses their knowledge and expertise to choose thespecific points used to measure the nasal valve collapse andcorresponding air flow rates. In this scenario the system then providesthe quantification of the data based on the physician selected times forthe measurement. Typically, measurements are not used where there is asteep transition or change in the air flow rate as these areas mayresult in blurry images or images with poor resolution. A moreconsistent and flat region of the air flow versus time plot isdesirable. In some embodiments the physician selects a zero flow or atrest position to observe the lateral wall in a relaxed state. Thephysician can observe the lateral wall position at another air flowrate, typically the point of maximum collapse for a given inspiration.For a given inspiration cycle the physician would select a point wherethe air flow is stable and the curve is at a plateau. The plateauhappens when there is flow limiting typically based on the nasal anatomyand air pathway.

In some embodiments the physician instructs the user to take varyinginspiration magnitudes such as a small inspiration, medium inspiration,and a large inspiration. The goal is to observe the nasal anatomy atdifferent air flow rates to generate data for plotting nasal valvecollapse versus air flow rate as discussed in detail with respect toFIGS. 7A-7B.

The physician can observe the patient for a predetermined number ofinspirations or breathing patterns or until a desired amount of data hasbeen received. In some cases it may be possible to obtain enough data onthe lateral wall based on a single inspiration observed by the patient.For example if the air flow rate varies enough over the course of theinspiration then enough discrete measurements may be achieved to make alinear plot as described in FIGS. 7A-7B.

In some cases the nasal valve can be observed in a static state tocompare the static size to lateral wall configuration in a dynamicstate.

In some embodiments the operator of the endoscope can make a marking onthe septum and lateral wall to facilitate observing the movement of thelateral wall and make it easier to determine the points at which tomeasure the nasal valve collapse. Marking the lateral wall and septumcan also make it more likely that the distance is accurately measuredbetween the septum and lateral wall. For example, the orientation of theendoscope and flexibility of the lateral wall can make it difficult tocompare the relative position of the lateral wall to the septum for agiven point in air pathway. It some cases with the flexible lateral wallthe user could inadvertently measure the distance between the septum anda point of the lateral wall that is posterior or anterior to the pointof the lateral wall. The marking can be done using a pen color that isin the visible spectrum. In some cases the pen can be applied bytouching a portion of the endoscope containing the ink such thatcapillary action causes the ink to flow and mark the surface of theseptum/lateral wall.

FIGS. 8A-8B illustrate additional examples of a graphical user interface(GUI) that can be used with methods for quantifying the nasal valvecollapse in accordance with some embodiments. FIGS. 8A-8B illustrate areview mode for the GUI 300. The GUI 300 shows a variety of informationrelating to the patient for the physician to review and analyze. The GUI300 shows patient number, location of the test, test protocol, date, andother information. The GUI 300 indicates that the physician is in reviewmode. The GUI 300 provides an image of the nasal valve along withspecific details of the frame and other related data such as theinspiration level for that particular image. The illustrated image ofthe nasal valve shows markings on the septum and lateral wall that canbe used by the physician to facilitate the determination of the distancebetween the septum and the lateral wall. The GUI 300 also includes aplot of air flow in SLPM versus time. The plot of air flow in SLPM canbe used by the physician to select a specific point in time along theplot such that after the time is selected the corresponding image of thenasal valve is shown to the physician. The GUI 300 provides a toggle orbutton feature to annotate the image for the nasal valve collapsequantification. The physician can click on the “baseline” or“inspiration” button, as appropriate, followed by annotating the imageto draw a line between the septum and the lateral wall. After the GUI300 has received the baseline and inspiration lines, the nasal valvecollapse can be calculated and provided as a percentage as shown on theGUI 300. After several data points have been received by the system agraph of the nasal valve collapse versus airflow can be generated andpresented to the user. Example of the graphs are shown in FIGS. 7A-7B.

FIGS. 7A-7B illustrate examples of graphs of nasal valve collapse versusairflow in standard liters per minute (SLPM) obtained using the systemsand methods described herein. For many patients the nasal valve collapseversus air flow rate has a substantially linear relationship with theslope of the line corresponding to the spring constant for the lateralwall. FIG. 7A shows the collapse for the patient's left nostril beforeand after providing an implant to stiffen the lateral wall. The beforeand after plots are each based on five data points with the dotted linescorresponding to a linear fit of the data points. The graph in FIG. 7Aclearly shows the improvement of the implant that is used to stiffen thelateral wall with the significantly flatter slope of the fit line alongwith the overall lower collapse values post lateral wall stiffening.FIG. 7B shows the collapse for the patient's left nostril before andafter providing an implant to stiffen the lateral wall. In FIG. 7B thebefore and after plots are each based on three data points with thedotted lines corresponding to a linear fit of the data points. The graphin FIG. 7B also clearly shows the improvement of the implant that isused to stiffen the lateral wall with the significantly flatter slope ofthe fit line along with the overall lower collapse values post lateralwall stiffening.

In some cases the relationship between the air flow rate and nasal valvecollapse can have a non-linear relationship. In some embodiments the airflow rate and nasal valve collapse can be modeled using a morecomplicated equation. For example, more complicated models can be usedfor patients with significant nasal valve collapse like full collapse orclose to full collapse of the nasal valve.

Data for the patients obtained using the system can be aggregated todetermine ranges for the spring constant of the lateral wall. The springconstant values can be classified into various categories such asflexible, average, and stiff.

The spring constant value for the patient anatomy can be measured asdescribed herein and considered by the physician treating the patient asone piece of information used to diagnose and treat the breathing issuesthat the patient may be experiencing. For example, the spring constantof the lateral wall and overall size of the nasal valve can be takeninto consideration when developing a treatment plan for the patient. Forexample, a flexible spring constant of the lateral wall and a small sizeof the nasal valve may indicate that using a nasal implant to stiffenthe nasal valve may be beneficial for the patient. In another example, astiffer spring constant of the lateral wall and/or a large size of thenasal valve may indicate that the nasal obstruction is primarily due toseptum or turbinate related issues. In this scenario using a nasalimplant to stiffen the nasal valve may be less likely to benefit thepatient.

FIG. 9 illustrates a device that can be used to measure the deflectionof the lateral wall 402 of the nose 400 of a patient in accordance withsome embodiments. The device 404 includes a plunger 408 that can bepushed against the lateral wall 402 of the nose 400 to measure the forceon the force dial 406 for a given deflection. The device 404 can includea ruler 410 or markings such that the force is measured for a desiredeflection length. The desired deflection length can be selected basedon the physician preferences, configuration of the device 400, patientanatomy, etc. In some embodiments the desired deflection length is 3 mm.There can be a mark on the plunger of the device 404 to show the desireddeflection length. The user can record the peak force shown on the forcedial 406 when the desire deflection length has been achieved. In someembodiments the desired deflection length can be less than about 10 mm,9 mm, 8 mm, 7 mm, 6 mm, 5 mm, 4 mm, 3 mm, 2 mm, or 1 mm. The forcereading at the desired deflection can be obtained and compared to thespring constant value ranges measured herein. The device 404 can be aquick, easy, and convenient way to get an indication of the propertiesof the lateral wall of the patient. This piece of information can beuseful in the diagnoses and treatment of the patient. In someembodiments the device 404 can optionally include a patient engagementsurface that can rest against a portion of the face of the patient toassist with steadying the device and orientation of the device relativeto the patient while measuring the force for the desired deflectionlength.

When a feature or element is herein referred to as being “on” anotherfeature or element, it can be directly on the other feature or elementor intervening features and/or elements may also be present. Incontrast, when a feature or element is referred to as being “directlyon” another feature or element, there are no intervening features orelements present. It will also be understood that, when a feature orelement is referred to as being “connected”, “attached” or “coupled” toanother feature or element, it can be directly connected, attached orcoupled to the other feature or element or intervening features orelements may be present. In contrast, when a feature or element isreferred to as being “directly connected”, “directly attached” or“directly coupled” to another feature or element, there are nointervening features or elements present. Although described or shownwith respect to one embodiment, the features and elements so describedor shown can apply to other embodiments. It will also be appreciated bythose of skill in the art that references to a structure or feature thatis disposed “adjacent” another feature may have portions that overlap orunderlie the adjacent feature.

Terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the invention.For example, as used herein, the singular forms “a”, “an” and “the” areintended to include the plural forms as well, unless the context clearlyindicates otherwise. It will be further understood that the terms“comprises” and/or “comprising,” when used in this specification,specify the presence of stated features, steps, operations, elements,and/or components, but do not preclude the presence or addition of oneor more other features, steps, operations, elements, components, and/orgroups thereof. As used herein, the term “and/or” includes any and allcombinations of one or more of the associated listed items and may beabbreviated as “/”.

Spatially relative terms, such as “under”, “below”, “lower”, “over”,“upper” and the like, may be used herein for ease of description todescribe one element or feature's relationship to another element(s) orfeature(s) as illustrated in the figures. It will be understood that thespatially relative terms are intended to encompass differentorientations of the device in use or operation in addition to theorientation depicted in the figures. For example, if a device in thefigures is inverted, elements described as “under” or “beneath” otherelements or features would then be oriented “over” the other elements orfeatures. Thus, the exemplary term “under” can encompass both anorientation of over and under. The device may be otherwise oriented(rotated 90 degrees or at other orientations) and the spatially relativedescriptors used herein interpreted accordingly. Similarly, the terms“upwardly”, “downwardly”, “vertical”, “horizontal” and the like are usedherein for the purpose of explanation only unless specifically indicatedotherwise.

Although the terms “first” and “second” may be used herein to describevarious features/elements (including steps), these features/elementsshould not be limited by these terms, unless the context indicatesotherwise. These terms may be used to distinguish one feature/elementfrom another feature/element. Thus, a first feature/element discussedbelow could be termed a second feature/element, and similarly, a secondfeature/element discussed below could be termed a first feature/elementwithout departing from the teachings of the present invention.

Throughout this specification and the claims which follow, unless thecontext requires otherwise, the word “comprise”, and variations such as“comprises” and “comprising” means various components can be co-jointlyemployed in the methods and articles (e.g., compositions and apparatusesincluding device and methods). For example, the term “comprising” willbe understood to imply the inclusion of any stated elements or steps butnot the exclusion of any other elements or steps.

As used herein in the specification and claims, including as used in theexamples and unless otherwise expressly specified, all numbers may beread as if prefaced by the word “about” or “approximately,” even if theterm does not expressly appear. The phrase “about” or “approximately”may be used when describing magnitude and/or position to indicate thatthe value and/or position described is within a reasonable expectedrange of values and/or positions. For example, a numeric value may havea value that is +/−0.1% of the stated value (or range of values), +/−1%of the stated value (or range of values), +/−2% of the stated value (orrange of values), +/−5% of the stated value (or range of values), +/−10%of the stated value (or range of values), etc. Any numerical valuesgiven herein should also be understood to include about or approximatelythat value, unless the context indicates otherwise. For example, if thevalue “10” is disclosed, then “about 10” is also disclosed. Anynumerical range recited herein is intended to include all sub-rangessubsumed therein. It is also understood that when a value is disclosedthat “less than or equal to” the value, “greater than or equal to thevalue” and possible ranges between values are also disclosed, asappropriately understood by the skilled artisan. For example, if thevalue “X” is disclosed the “less than or equal to X” as well as “greaterthan or equal to X” (e.g., where X is a numerical value) is alsodisclosed. It is also understood that the throughout the application,data is provided in a number of different formats, and that this data,represents endpoints and starting points, and ranges for any combinationof the data points. For example, if a particular data point “10” and aparticular data point “15” are disclosed, it is understood that greaterthan, greater than or equal to, less than, less than or equal to, andequal to 10 and 15 are considered disclosed as well as between 10 and15. It is also understood that each unit between two particular unitsare also disclosed. For example, if 10 and 15 are disclosed, then 11,12, 13, and 14 are also disclosed.

Although various illustrative embodiments are described above, any of anumber of changes may be made to various embodiments without departingfrom the scope of the invention as described by the claims. For example,the order in which various described method steps are performed mayoften be changed in alternative embodiments, and in other alternativeembodiments one or more method steps may be skipped altogether. Optionalfeatures of various device and system embodiments may be included insome embodiments and not in others. Therefore, the foregoing descriptionis provided primarily for exemplary purposes and should not beinterpreted to limit the scope of the invention as it is set forth inthe claims.

The examples and illustrations included herein show, by way ofillustration and not of limitation, specific embodiments in which thesubject matter may be practiced. As mentioned, other embodiments may beutilized and derived there from, such that structural and logicalsubstitutions and changes may be made without departing from the scopeof this disclosure. Such embodiments of the inventive subject matter maybe referred to herein individually or collectively by the term“invention” merely for convenience and without intending to voluntarilylimit the scope of this application to any single invention or inventiveconcept, if more than one is, in fact, disclosed. Thus, althoughspecific embodiments have been illustrated and described herein, anyarrangement calculated to achieve the same purpose may be substitutedfor the specific embodiments shown. This disclosure is intended to coverany and all adaptations or variations of various embodiments.Combinations of the above embodiments, and other embodiments notspecifically described herein, will be apparent to those of skill in theart upon reviewing the above description.

What is claimed is:
 1. A system for measuring a nasal valve collapse ofa patient comprising: a facial mask adapted to form a seal with a facialstructure of the patient, the facial mask including an endoscope portand an opening to allow air flow; an air flow sensor in fluidcommunication with the opening of the facial mask configured to measurean air flow across the opening; an endoscope with a camera adapted topass through the endoscope port in the facial mask and image a nasalvalve; and a data acquisition module configured to: receive a pluralityof images from the camera and a plurality of air flow measurements fromthe air flow sensor, determine, based on the air flow measurements, (i)a first image of the plurality of images of the nasal valve taken duringinhalation and (ii) a second image of the plurality of images of thenasal valve taken during a period between exhalation and inhalation, anddetermine, based on the first image and the second image, a sizedifference of the nasal valve during inhalation and during the periodbetween exhalation and inhalation.
 2. The system of claim 1, wherein, todetermine the size difference of the nasal valve, the data acquisitionmodule is configured to: determine, based on the first image, a firstdistance between a septum and a lateral wall of the nasal valve duringinhalation, determine, based on the second image, a second distancebetween the septum and the lateral wall of the nasal valve during theperiod between exhalation and inhalation, and determine the sizedifference by dividing the first distance by the second distance.
 3. Thesystem of claim 1, wherein the plurality of images are taken during aplurality of inhalation rates, wherein the plurality of inhalation ratesare different from each other, and wherein the data acquisition moduleis further configured to, for each inhalation rate, determine a relativedistance between a septum and a lateral wall of the nasal valve.
 4. Thesystem of claim 3, further comprising a display device that isconfigured to display a graph of (i) the relative distances between theseptum and the lateral wall of the nasal valve at the plurality ofinhalation rates versus (ii) the air flow measurements at the pluralityof inhalation rates.
 5. The system of claim 1, further comprising adisplay device configured to display a graphical user interface (GUI).6. The system of claim 5, wherein the graphical user interface (GUI) isconfigured to display (i) an image of the plurality of images taken at afirst time and (ii) an air flow measurement measured at the first time.7. The system of claim 5, wherein the data acquisition module is furtherconfigured to: receive an annotation of the first image of the nasalvalve during inhalation, wherein the annotation of the first imageindicates a distance between a septum and a lateral wall of the nasalvalve in the first image; determining a first distance between theseptum and the lateral wall based on the annotation of the first imageof the nasal valve during inhalation; receive an annotation of thesecond image of the nasal valve during the period between exhalation andinhalation, wherein the annotation of the second image indicates adistance between the septum and the lateral wall of the nasal valve inthe second image; and determine a second distance between the septum andthe lateral wall based on the annotation of the second image of thenasal valve during the period between exhalation and inhalation; anddetermine the size difference of the nasal valve based on the firstdistance and the second distance.
 8. The system of claim 7, wherein thegraphical user interface (GUI) is configured to display the annotationof the first image and the annotation of the second image.
 9. The systemof claim 7, wherein the annotation of the first image comprises a lineacross the nasal valve between the lateral wall and the septum in thefirst image, and the annotation of the second image comprises a lineacross the nasal valve between the lateral wall and the septum in thesecond image.
 10. The system of claim 7, wherein the annotation of thefirst image, comprises a tracing of a perimeter of the nasal valve inthe first image, and the annotation of the second image comprises atracing of the perimeter of the nasal valve in the second image.
 11. Thesystem of claim 5, wherein the graphical user interface (GUI) isconfigured to display a graph including the air flow measurements versustime.
 12. The system of claim 11, wherein the graphical user interface(GUI) is configured to: receive an input from a user indicating a timeof interest on the graph; and display an image of the plurality ofimages of the nasal valve that was taken at the time of interest. 13.The system of claim 5, wherein the graphical user interface isconfigured to display a graph of a quantification of the nasal valvecollapse at a plurality of inhalation rates versus air flow rate. 14.The system of claim 1, wherein the data acquisition module is configuredto apply image analysis to the first image to automatically measure anarea of space between a septum and a lateral wall to automaticallydetermine an area or a length of the septum and a lateral wall.
 15. Thesystem of claim 1, wherein the camera is configured to capture theplurality of images as a video of the nasal valve.
 16. The system ofclaim 1, wherein the data acquisition module is configured tosynchronize the plurality of images from the camera and the plurality ofair flow measurements from the air flow sensor using a plurality of timestamps associated with the plurality of images and the plurality of airflow measurements.
 17. The system of claim 1, wherein the dataacquisition module is configured to determine the size difference of thenasal valve during inhalation and during the period between exhalationand inhalation calculating a percentage difference in an area or one ormore dimensions of the nasal valve during inhalation and the periodbetween exhalation and inhalation.
 18. A method for determining one ormore properties of a nose, comprising: pushing a plunger of a deviceagainst a lateral wall of the nose; determining, using a marking on thedevice, that the lateral wall of the nose has been deflected by apredetermined deflection length; and while the lateral wall of the noseis deflected by the predetermined deflection length, measuring, usingthe device, a force applied by the plunger against the lateral wall ofthe nose; and comparing the force measured by the device to a range ofvalues to determine one or more properties of the nose.
 19. The methodof claim 18, wherein the range of values is based on a spring constant.20. The method of claim 18, wherein measuring the force comprisesmeasuring the force using a force dial of the device.